Note that only one regulatory activity is to be submitted per email. Return to table 1 footnote d referrer. A first iteration of this document was developed to include DIN applications and published in June Return to table G-2 footnote 6 referrer. Drug Product Dosage Forms:
A code created by Health Canada to uniquely identify the dossier. Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Table 3 footnotes Table 3 footnote 1 Required only for Clinical Trial regulatory activities. PRAC will create 1 report using a single assessment framework for all products with the same active substance and share it with the relevant MA holders. In addition, the following are exceptions to this requirement: Division 5 Sample Folder Structure s. In February , the third iteration widening the scope to introduce Part C, Division 5 and Division 8 human drugs of the Food and Drugs Regulations was published.
X Table 1 footnote lettet. Return to table G-2 footnote 1 referrer. It is the responsibility of the stakeholder preparing the regulatory transaction to ensure that hyperlinks are functioning.
Division 8 Regulatory Activities. Sample folder structure for a Response to a Clarification Request for human drugs Figure 2 – displays a sample folder structure requirement for a response to a clarification request.
Heads of Medicines Agencies: PSUR
However, Health Canada suggests that the file names be kept as brief and meaningful as possible:. In addition, the following are exceptions to this requirement:. Return to table G-1 footnote 3 referrer.
Guidance Periodic benefit risk evaluation reports for medicinal products. Should clearly indicate the name of the requester. Zip file – 9 K.
Return to table G-2 footnote 2 referrer. Technical Requirements for Regulatory Activities 3.
For human drugsthese should be placed in folders 1. Clinical Trial Applications for further clarity. Division 5 Figure D Regulatory transactions provided by email should meet the following requirements:. When providing a revision to the MF the version number should be updated.
Marketing authorisation templates | European Medicines Agency
Return to table G-2 footnote 5 referrer. Additional specific requirements for transactions accepted via email include: The attached zipped folder structure in the HTML version of this document can be used by adding documents in their respected folders. Thumbnail Cache Files Thumbs.
See Lftter F for illustrations. Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations.
X Table 1 footnote g.
Marketing authorisation templates
It will take only 2 minutes to fill in. O Table 1 footnote g. The following are common folders structure errors to avoid: If only one page of a multi-page document requires a signature, the sponsor should letetr that page and then include the scanned page at the same location in the PDF file of the document.
A document describing the information being provided e.
Periodic benefit risk evaluation reports for medicinal products
A first iteration of this document was developed to covef DIN applications and published in June What were you doing? To help us improve GOV.
Note that the required hyperlinks to related information should be included only in the PDF version of files. The subject line of the emails should include the statement: A link, button or video is not working.